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A A032 151 UNcLASSIFIEDROYAL NAVAL PERSONNEL RESEARCH COMMITTEE LONDON (ENGLAND) FIG 6/19 SIGNAL DETECTION EFFICIENCY IN THE MORNING WATCH. EFFECTS OF PRETC(U) MAR us w P CALHOUN. P HAMILTON. Ft S
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Signal detection efficiency refers to the effectiveness of a system or process in identifying and responding to signals, particularly in the context of monitoring adverse events and ensuring safety in pharmaceutical and medical product use.
Pharmaceutical companies and medical device manufacturers are typically required to file signal detection efficiency reports as part of their regulatory obligations to ensure the safety and effectiveness of their products.
To fill out signal detection efficiency, companies must gather relevant data, analyze signal trends, complete a standardized reporting form, and provide detailed explanations of methodologies and findings related to signal detection.
The purpose of signal detection efficiency is to ensure that potentially harmful signals related to product safety are detected promptly, to facilitate timely regulatory action, and to protect public health.
Information that must be reported includes the nature of the signal detected, data analysis methods used, the outcomes of the analysis, any actions taken in response, and recommendations for further monitoring.
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